de Juan Bagudá Javier, Severo Sánchez Andrea, de la Espriella Rafael, Valero-Masa María Jesús, García-Vega David, de Antonio Ferrer Marta, Segura de la Cal Teresa, Mollar Anna, García-Cosío Carmena María Dolores, Martínez-Dolz Luis, de la Cruz Javier, González-Juanatey José R, Martínez-Sellés Manuel, Núñez Julio, Delgado Jiménez Juan F
Cardiology. Instituto de Investigación Sanitaria Hospital 12 de Octubre (imas12), Hospital Universitario 12 de Octubre, Madrid, Spain
Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.
Heart. 2025 Aug 28. doi: 10.1136/heartjnl-2025-326053.
Current evidence supports the role of circulating carbohydrate antigen 125 (CA125) in risk assessment, disease monitoring and therapeutic guidance in heart failure (HF). However, there is limited data on its diagnostic applicability. This study aimed to assess the diagnostic performance of CA125 in identifying HF with preserved ejection fraction (HFpEF) in an outpatient population.
This was a prospective, multicentre study involving 246 consecutive patients with clinically suspected HF. Patients with a left ventricular ejection fraction <50% (n=8) and those with a history of malignancy (n=22) were excluded. The final study cohort comprised 210 patients. The diagnosis of HFpEF was confirmed by a trained cardiologist blinded to the biomarker levels.
The mean age of the study cohort was 69.7±15 years, and 69% were women. Median levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP) and CA125 were 125 pg/mL (IQR: 51-332) and 11 U/mL (IQR: 8-17), respectively. HFpEF was diagnosed in 65 (31%) patients. For HFpEF diagnosis, NT-proBNP and CA125 levels demonstrated comparable areas under the receiver operating characteristic curves 0.765 (95% CI: 0.686 to 0.843) vs 0.715 (95% CI: 0.636 to 0.793), respectively (p=0.323). Optimal cut points were identified as 12.2 U/mL for CA125 (sensitivity: 0.69; specificity: 0.68) and 243 pg/mL for NT-proBNP (sensitivity: 0.65; specificity: 0.83). Elevated CA125 levels (>23 U/mL, 12.4% of the sample) exhibited high specificity (0.97), a positive predictive value of 80.8% and correctly classified 77.1% of cases as HFpEF. Conversely, CA125 levels<9 U/mL were associated with a high negative predictive value (85.7%).
In an ambulatory setting, CA125 exhibits acceptable diagnostic performance for identifying HFpEF and may complement NT-proBNP in clinical practice.
目前的证据支持循环糖类抗原125(CA125)在心力衰竭(HF)的风险评估、疾病监测和治疗指导中的作用。然而,关于其诊断适用性的数据有限。本研究旨在评估CA125在门诊人群中识别射血分数保留的心力衰竭(HFpEF)的诊断性能。
这是一项前瞻性、多中心研究,纳入246例临床疑似HF的连续患者。排除左心室射血分数<50%的患者(n = 8)和有恶性肿瘤病史的患者(n = 22)。最终研究队列包括210例患者。HFpEF的诊断由一名对生物标志物水平不知情的训练有素的心脏病专家确认。
研究队列的平均年龄为69.7±15岁,69%为女性。N末端B型利钠肽原(NT-proBNP)和CA125的中位数水平分别为125 pg/mL(IQR:51 - 332)和11 U/mL(IQR:8 - 17)。65例(31%)患者被诊断为HFpEF。对于HFpEF诊断,NT-proBNP和CA125水平在受试者工作特征曲线下的面积分别为0.765(95%CI:0.686至0.843)和0.715(95%CI:0.636至0.793),具有可比性(p = 0.323)。CA125的最佳切点确定为12.2 U/mL(敏感性:0.69;特异性:0.68),NT-proBNP为243 pg/mL(敏感性:0.65;特异性:0.83)。CA125水平升高(>23 U/mL,占样本的12.4%)表现出高特异性(0.97),阳性预测值为80.8%,并将77.1%的病例正确分类为HFpEF。相反,CA125水平<9 U/mL与高阴性预测值(85.7%)相关。
在门诊环境中,CA125在识别HFpEF方面表现出可接受的诊断性能,并且在临床实践中可能补充NT-proBNP。